We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Our client is seeking a System Owner Engineer to support the expansion of formulation and sterilisation systems, including formulation skids, single-use systems, autoclaves, and parts washers.

This role is critical to ensuring sterile manufacturing readiness and equipment reliability.

Key Responsibilities:

• Act as System Owner(SO) for formulation and sterilisation equipment.
• SO during the implementation, commissioning, qualification, and validation activities.
• Own system performance, reliability, and lifecycle management.
• Develop and implement:
  • Maintenance strategies
  • PM programs
  • Calibration strategy
  • Spare parts strategy
• Ensure equipment meets GMP, data integrity, and regulatory compliance requirements.
• Provide technical oversight during deviations, investigations, and audit responses.
• Support operational readiness and training of end users.
• Collaborate with cross-functional stakeholders across Engineering, Quality, Automation, Validation, and Manufacturing.

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Chemical or related discipline).
• 5+ years’ experience in GMP biopharmaceutical manufacturing environments.
• Hands-on experience with: Formulation systems, Single-use mixing technologies, Autoclaves (steam sterilisation), Parts washers (cleaning validation exposure preferred)
• Strong understanding of sterilisation principles and cleaning validation requirements.
• Experience supporting regulatory inspections and audit readiness.
• Strong project execution and technical problem-solving capability.